🏛️ Verified NIH Record • Updated 2026-02-24
Setrusumab vs Placebo for Osteogenesis Imperfecta (NCT05125809)
An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta
🔵 Active, Not Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Ultragenyx Pharmaceutical Inc
🩺 Plain-English Summary (8th-Grade Level)
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.
Who can join: Review the eligibility criteria below.
Location: Arkansas Children's Hospital — Little Rock, Arkansas
Age range: 5 Years to 25 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (44 Sites)
Showing the first 25 of 44 sites.
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's Hospital Los Angeles — Los Angeles, California
- Shriners Hospital for Children - Northern California — Sacramento, California
- Children's Hospital Colorado — Aurora, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut
- Nemours/ Alfred i. duPoint Hospital for Children — Wilmington, Delaware
- Children's National Medical Center — Washington D.C., District of Columbia
- University of South Florida — Tampa, Florida
- Shriners Hospitals for Children - Chicago — Chicago, Illinois
- Indiana University Hospital — Indianapolis, Indiana
- Kennedy Krieger Institute — Baltimore, Maryland
- Boston Children's Hospital — Boston, Massachusetts
- Washington University School of Medicine — St Louis, Missouri
- Children's Hospital and Medical Center — Omaha, Nebraska
- New Mexico Clinical Research & Osteoporosis Center, Inc. — Albuquerque, New Mexico
- Atrium Health Levine Children's Hospital — Charlotte, North Carolina
- Nationwide Children's Hospital- Ohio State University College of Medicine — Columbus, Ohio
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- Cook Children's Medical Center — Fort Worth, Texas
- Baylor College of Medicine — Houston, Texas
- UW Health University Hospital — Madison, Wisconsin
- Queensland Paediatric Endocrinology — South Brisbane, Queensland
- Royal Children's Hospital — Melbourne,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteogenesis Imperfecta
- Dental Malocclusion and Craniofacial Development in OI — Los Angeles, California
- Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708 — Los Angeles, California
- Clear Aligners for the Treatment of Dental Malocclusion in OI — Los Angeles, California
- Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta — Birmingham, Alabama
- Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta — Phoenix, Arizona
Explore by condition: All Osteogenesis Imperfecta clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.